Post Stroke Intensive Rehabilitation

Stroke Rehabilitation Clinical Trial

— PSR  

Official title:

Post Stroke Intensive Rehabilitation: Predictors of Outcome and Response to Specific Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03866057
• Other study ID #: FDG_STROKE
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Francesca Cecchi, Physician
• Phone: 05573931
• Email: fcecchi[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective observational cohort study, with 6 months follow up, to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke. All patients will be evaluated with a standardized protocol. Functional recovery will be assessed at the discharge and after a period of 6 months.

Description:

Despite progress in the treatment of cerebrovascular diseases in the acute phase, stroke remains a catastrophic event with important public health implications. Post-acute intensive rehabilitation is recommended in patients with neurological deficits, but standardized evaluation protocols are essential for evaluate the efficacy of rehabilitation and for the early identification of prognostic factors of recovery. The search for biomarkers of response to specific treatments aimed to customizing the intervention. Recent studies highlight the importance of neurophysiological markers as predictors of post-stroke epilepsy onset and prognosis. Also genetic substrate and epigenetic mechanisms have a prognostic role; the latter may be modified by the administration of Selective Serotonin Reuptake Inhibitor (SSRI) drugs, largely prescribed according to guidelines in post-stroke depression, confirming the neurotrophic role of these drugs postulated in many studies but never demonstrated in vivo in humans. Specific physiotherapeutic interventions also seem to stimulate optimal functional recovery and brain neuroplasticity, in particular those based on the intensive repetition of tasks, such as robotics and Mirror Therapy. Given that the mechanisms of neuronal plasticity activated by these interventions are presumably different, it is hypothesizable that there are specific predictors of response for each of them.

The primary endpoint of this study is to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke, evaluated with standardized protocol. Recovery will be assessed at discharge and at follow-up after 6 months.

Secondary endpoints are:

• evaluate the development of post-stroke epilepsy according to the presence of early clinical seizures or electroencephalographic (EEG) anomalies identified at admission to rehabilitation;

• demonstrate in vivo the activation of neuroplasticity by serotonin reuptake inhibitors drugs;

• evaluate in patients with hemiplegia / hemiparesis of upper limb undergoing Mirror Therapy, robotic rehabilitation and traditional physiotherapy, the presence of specific factors predictive of functional recovery, and of response to different treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion criteria:

• age 18-90

• acute ischemic or hemorrhagic stroke (within 30 days)

• consent to participate and to anonymous processing of data.

Additional inclusion criteria for Sub-project Neurophysiological Markers:

-signing of informed consent for the participation in the sub-project.

Additional inclusion criteria for Epigenetic subproject:

-signing of informed consent for participation in the subproject.

Exclusion Criteria:

-Stroke occurred more than 30 days after the transfer to intensive rehabilitation

Additional exclusion criteria for Epigenetic subproject (for retrospective analysis):

• history of major psychiatric disorder or recent exacerbation

• global aphasia

• refusal of the patient to participate in the study.

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Locations

Country	Name	City	State
Italy	Fondazione don Gnocchi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Modified Barthel Index (mBI)	Functional recovery; Score from 0 to 100; higher values represent a better outcome.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in Modified Rankin score	Functional recovery; Score from 0 to 6; higher values represent a worse outcome.	Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in Fugl Meyer Assessment (FMA)	Sensomotor recovery; Total score from 0 to 64, Upper-limb subscale 0-36; lower-limb subscale 0-28. Higher values represent a better outcome.	Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in communication ability (Scala di disabilità comunicativa -SDC)	Communication recovery; Score from 0 to 4; higher values represent a better outcome.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in Oxford Cognitive Score (OCS)	The Oxford Cognitive Screen (OCS) describes the cognitive deficits after stroke.The scale consists of 10 tasks encompassing five cognitive domains: attention and executive function, language, memory, number processing, and praxis.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in Hospital Anxiety and Depression Scale (HADS)	depression and anxiety; Score from 0 to 21, subitems Depression and Anxiety. Higher values represent a worse outcome.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in Functional Ambulation Classification (FAC)	Walking recovery; Score from 0 to 5. Higher values represent a better outcome.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in Trunk Control Test (TCT)	Trunk control recovery; Score from 0 to 100;Higher values represent a better outcome.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in Numeric Rating Score (NRS) -Pain	Pain assessment; Score from 0 to 10; Higher values represent a worse outcome.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in Ashworth spasticity scale	Spasticity; Score from 0 to 4; Higher values represent a worse outcome.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in National Institute of Health Stroke Scale (NIHSS)	clinical recovery; 15 items scored from 3 to 4 ( total score from 0 to 42). Higher values represent a worse outcome.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	Post Stroke Epilepsy	We will report possible post stroke seizures.	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary	change in serum Brain Derived Neurotrophic factor (BDNF) epigenetic profile	Neural plasticity	Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2